Associate Director, Drug Product

About CG Oncology, Inc.

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world.

Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you.

About the role

The Associate Director, Drug Product will serve as a technical and operational leader responsible for late-stage development, manufacturing, and commercialization activities for small molecule and/or viral drug products. Through operational oversight, technical mentorship, and cross-functional collaboration, the Associate Director will ensure drug product development and manufacturing deliverables across clinical and commercial programs is robust, compliant, and aligned with overall program objectives. The ideal candidate brings extensive hands-on experience in drug product process development and manufacturing, strong partnership experience with contract development and manufacturing organizations (CDMOs), proven ability to lead, develop, and mentor high-performing teams, and demonstrated success authoring drug product modules for BLAs and global marketing applications. Experience with viral formulations, in-use compatibility studies, and ex-US regulatory pathways is strongly preferred.

Location: Remote

Essential Functions

• Drug Product Development & Manufacturing
• • Provide technical and operational leadership across all aspects of drug product development and manufacturing for small molecule and/or viral products, including formulation, fill-finish, and clinical in use studies.
  • Contribute to regulatory strategy for late-stage and commercial programs, ensuring alignment with current guidances and global expectations.
  • Author and review drug product sections of regulatory filings, including BLA and responses to health authority information requests.
  • Partner closely with drug substance, analytical development, quality assurance, quality control, supply chain, and regulatory groups to ensure alignment across CMC activities.
  • Support management of external manufacturing sites in collaboration with technical SMEs to ensure aligned decision-making and smooth execution.
  • Provide technical guidance on post-approval changes and lifecycle management strategies.
  • Provide leadership by aligning priorities, developing talent, and empowering teams to deliver outcomes independently.

Qualifications

• Advanced degree (PhD, MS, or BS with extensive experience) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.
• 8+ of relevant industry experience in drug product development and manufacturing for biologics and/or cell and gene therapy products
• Deep technical knowledge of drug product process development and manufacturing, including formulation, aseptic processing, and clinical in-use studies.
• Strong understanding of cGMP, ICH guidelines, and late-stage/commercial regulatory expectations.
• Demonstrated success authoring drug product BLA sections and supporting regulatory interactions.
• Direct experience working with CDMOs and leading external manufacturing operations.
• Proven people leader who develops talent and empowers teams.
• Demonstrates strong cross‑functional leadership with the ability to navigate ambiguity and drive results in complex, fast‑paced environments.
• Excellent written and verbal communication skill

Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid.

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